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Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Diben 1.5 kcal HP
Fresubin HP Energy Fibre (1.5 kcal)
Sponsored by
Fresenius Kabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5
  • Requiring mechanical ventilation in the ICU at the time of enrolment

  • Enteral nutrition (EN) in the ICU at time of enrolment

    • If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay
    • If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment
  • Patients expected to stay in the ICU for at least 5 days following enrolment
  • Age 18 - 75 years
  • Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l)
  • Informed consent according to local regulations for decisionally impaired subjects

Exclusion Criteria:

  • Patients with septic shock at time of enrolment
  • Participation in a clinical trial with any investigational product within 4 weeks before study
  • Patients requiring a fibre free diet
  • Total or supplementary parenteral nutrition (> 20% of total calories)
  • Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia
  • Gastrectomy
  • Postpyloric nutrition
  • Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea)
  • Known severe heart failure (NYHA class 4)
  • Liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l)
  • Acute kidney failure (blood creatinine > 2.5 mg/dl)
  • Body Mass Index < 18 or > 35 kg/m²
  • Known or suspicion of drug abuse
  • Pregnant or breast feeding women
  • Patients with diabetes mellitus type I

Exclusion After Enrolment (Withdrawal of Subjects)

  • Start of PN with more than 20% of total given energy amount/ day
  • Insulin infusion stopped unexpectedly for > 12h for non-nutritional reasons
  • Discharge from ICU
  • Intolerable AEs
  • Major protocol violation
  • Withdrawal of informed consent
  • Discontinuation of study treatment for other reasons

Sites / Locations

  • Universitätsklinikum Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diben 1.5 kcal HP

Fresubin HP Energy Fibre (1.5 kcal)

Arm Description

Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)

Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)

Outcomes

Primary Outcome Measures

Blood glucose variability (within patient standard deviation of blood glucose values per day)

Secondary Outcome Measures

Glucose variability
Time to switch from intravenous to subcutaneous insulin administration
Insulin requirements in IU per day
Blood glucose levels
HbA1c
Difference between target and given enteral nutrition (Compliance)
Cerebral and subcutaneous microdialysis: glucose
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Hospital mortality
ICU mortality
ICU length of stay
Days of mechanical ventilation
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Gastro-intestinal intolerance (AEs, complications)

Full Information

First Posted
July 10, 2015
Last Updated
March 15, 2022
Sponsor
Fresenius Kabi
Collaborators
OE Clinical Trial Center (KKS) Universität Innsbruck, International Medical Research - Partner GmbH, dsh statistical services GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02503527
Brief Title
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
Official Title
Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Low Recruitment rate
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi
Collaborators
OE Clinical Trial Center (KKS) Universität Innsbruck, International Medical Research - Partner GmbH, dsh statistical services GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
Keywords
Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diben 1.5 kcal HP
Arm Type
Other
Arm Description
Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)
Arm Title
Fresubin HP Energy Fibre (1.5 kcal)
Arm Type
Other
Arm Description
Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)
Intervention Type
Other
Intervention Name(s)
Diben 1.5 kcal HP
Intervention Description
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
Intervention Type
Other
Intervention Name(s)
Fresubin HP Energy Fibre (1.5 kcal)
Intervention Description
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
Primary Outcome Measure Information:
Title
Blood glucose variability (within patient standard deviation of blood glucose values per day)
Time Frame
At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first
Secondary Outcome Measure Information:
Title
Glucose variability
Time Frame
Days 2, 4 and 5 of intervention
Title
Time to switch from intravenous to subcutaneous insulin administration
Time Frame
Days 1-6, daily
Title
Insulin requirements in IU per day
Time Frame
Days 1 - 6, daily
Title
Blood glucose levels
Time Frame
Days 1 - 6, daily
Title
HbA1c
Time Frame
Days 1, 6, 28
Title
Difference between target and given enteral nutrition (Compliance)
Time Frame
Days 2-6, daily
Title
Cerebral and subcutaneous microdialysis: glucose
Time Frame
Days 1 - 6, daily
Title
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Time Frame
Days 1 - 6, daily
Title
Hospital mortality
Time Frame
Day 28
Title
ICU mortality
Time Frame
Day 28
Title
ICU length of stay
Time Frame
Day 28
Title
Days of mechanical ventilation
Time Frame
Day 28
Title
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Time Frame
Days 2-6, daily
Title
Gastro-intestinal intolerance (AEs, complications)
Time Frame
Days 2-6, daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5 Requiring mechanical ventilation in the ICU at the time of enrolment Enteral nutrition (EN) in the ICU at time of enrolment If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment Patients expected to stay in the ICU for at least 5 days following enrolment Age 18 - 75 years Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l) Informed consent according to local regulations for decisionally impaired subjects Exclusion Criteria: Patients with septic shock at time of enrolment Participation in a clinical trial with any investigational product within 4 weeks before study Patients requiring a fibre free diet Total or supplementary parenteral nutrition (> 20% of total calories) Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia Gastrectomy Postpyloric nutrition Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea) Known severe heart failure (NYHA class 4) Liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l) Acute kidney failure (blood creatinine > 2.5 mg/dl) Body Mass Index < 18 or > 35 kg/m² Known or suspicion of drug abuse Pregnant or breast feeding women Patients with diabetes mellitus type I Exclusion After Enrolment (Withdrawal of Subjects) Start of PN with more than 20% of total given energy amount/ day Insulin infusion stopped unexpectedly for > 12h for non-nutritional reasons Discharge from ICU Intolerable AEs Major protocol violation Withdrawal of informed consent Discontinuation of study treatment for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronny Beer, PD Dr. med.
Organizational Affiliation
Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

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Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

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